Viracta Therapeutics Q1 2024 Financial Results and Business Update

Viracta Therapeutics, Inc., a clinical-stage precision oncology company focusing on virus-associated cancers, has reported promising first-quarter 2024 results and ongoing advancements in its clinical trials, specifically focusing on Nana-val, an all-oral combination therapy of nanatinostat and valganciclovir.

The pivotal Phase 2 NAVAL-1 trial, aimed at patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphomas, showcased positive topline results. This trial employs a two-stage design, and the data from Stage 1 exhibited significant efficacy for Nana-val, particularly for patients with peripheral T-cell lymphoma (PTCL). The results indicated that Nana-val had superior efficacy and a well-tolerated safety profile compared to nanatinostat monotherapy. The objective response rate (ORR) and complete response rate (CRR) for Nana-val were notably higher than those for nanatinostat alone, providing a strong validation for its combined mechanism of action. The company plans to present further data from Stage 1 and initial results from Stage 2 in the third quarter of 2024.

In addition to the NAVAL-1 trial, Viracta is progressing with its Phase 1b/2 study of Nana-val in patients with advanced EBV+ solid tumors. The study is on track to determine the recommended Phase 2 dose (RP2D) in the latter half of 2024. The company has successfully completed enrollment for the sixth dose cohort and initiated enrollment for the seventh cohort, both evaluating a novel split daily dosing regimen.

Notably, Viracta has achieved regulatory milestones in Japan by securing endorsement from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) to enroll patients directly into the NAVAL-1 trial without a preceding Japanese Phase 1 study. This regulatory progress facilitates an accelerated inclusion of Japanese patients in the pivotal trial.

Financially, Viracta reported a cash position of approximately $39.6 million as of March 31, 2024, expected to fund operations into the first quarter of 2025. The company incurred research and development expenses of around $10.0 million for the first quarter, primarily due to increased costs supporting clinical development programs and a non-cash adjustment for insurance costs associated with a reverse merger. General and administrative expenses were approximately $3.9 million, showing a decrease from the previous year mainly due to lower insurance premiums and legal costs. Viracta reported a net loss of $9.1 million for the first quarter of 2024, an improvement from the $12.2 million loss in the same period of 2023, largely attributable to other income received from the monetization of a milestone from Day One Biopharmaceuticals, Inc.

The NAVAL-1 trial (NCT05011058) is designed to evaluate the efficacy of Nana-val in various subtypes of R/R EBV+ lymphomas. The trial's promising results from Stage 1 have paved the way for expanded patient enrollment and potential accelerated approval discussions with the FDA. The ongoing Phase 1b/2 trial (NCT05166577) is evaluating Nana-val in combination with pembrolizumab for recurrent or metastatic EBV+ nasopharyngeal carcinoma (NPC) and other advanced EBV+ solid tumors.

Nana-val comprises nanatinostat, an orally available histone deacetylase (HDAC) inhibitor, and valganciclovir, an antiviral agent. The combination aims to target EBV-associated malignancies by inducing viral gene expression that is otherwise epigenetically silenced.

Peripheral T-cell lymphomas (PTCL) remain a challenging group of malignancies with high relapse rates, and EBV+ PTCL has particularly poor outcomes. Viracta's development of Nana-val addresses a significant unmet medical need in this area. EBV, a ubiquitous virus, is linked to about 2% of global cancer cases, including various lymphomas, NPC, and gastric cancer.

Viracta continues to advance its "Kick and Kill" approach, which seeks to exploit the vulnerabilities of EBV-associated malignancies, offering hope for better therapeutic options for patients worldwide.